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Intravenous Magnesium for Sickle Cell Vasoocclusive Crisis (MAGiC)

This study has been completed.
Sponsor:
Collaborator:
Pediatric Emergency Care Applied Research Network
Information provided by (Responsible Party):
Medical College of Wisconsin
ClinicalTrials.gov Identifier:
NCT01197417
First received: August 31, 2010
Last updated: December 21, 2015
Last verified: December 2015
  Purpose
The purpose of this study is to determine the safety and efficacy of intravenous magnesium in shortening the duration of a pain crisis and to determine the health-related quality of life and short term outcomes of children treated with intravenous magnesium during an acute pain crisis.

Condition Intervention Phase
Sickle Cell Disease
Drug: Intravenous Magnesium Sulfate
Drug: Normal Saline Placebo
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Intravenous Magnesium for Sickle Cell Vasoocclusive Crisis

Resource links provided by NLM:


Further study details as provided by Medical College of Wisconsin:

Primary Outcome Measures:
  • Hospital Length of Stay (Hours) [ Time Frame: From the time of the start of first study med infusion until hospital discharge or 12 hours after the last IV opioid, whichever occurs first, up to 10 days post enrollment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of Morphine Equivalents Per Kilogram of Body Weight Used During Hospitalization [ Time Frame: Total morphine equivalents used during the hospitalization will be recorded on the day of discharge, up to 10 days post enrollment ] [ Designated as safety issue: No ]
  • Hypotension Associated With Infusion [ Time Frame: Blood pressure will be monitored every 8 hours, concurrent with each infusion, and for 20-30 minutes after infusion completion, until discharge, up to 2 days post enrollment ] [ Designated as safety issue: Yes ]
    For each study drug infusion, systolic blood pressure (SBP) was measured just prior to the start of the infusion and again every 10 minutes until 30 minutes until the end of the infusion. Hypotension was defined as a greater than 20% reduction in SBP relative to corresponding baseline measurement for any study drug infusion.

  • Warm Sensation Associated With Study Drug Infusion [ Time Frame: Patient-reported warm sensation upon infusion will be monitored every 8 hours, concurrent with each infusion, and for 20-30 minutes after infusion completion, until discharge, up to 2 days post enrollment ] [ Designated as safety issue: Yes ]
    Patient spontaneously reported feelings of warmth during any study drug infusion.

  • Rehospitalization [ Time Frame: Rehospitalization will be measured at 7 days post discharge and at the follow-up visit (on average, 30 days post discharge) ] [ Designated as safety issue: Yes ]
  • Development of Acute Chest Syndrome (ACS) [ Time Frame: Patients will be monitored daily, on average, during their length of stay until discharge, up to 10 days post enrollment ] [ Designated as safety issue: Yes ]
  • Hospital Length of Stay [ Time Frame: Start of first study drug infusion to actual hospital discharge ] [ Designated as safety issue: No ]

Enrollment: 208
Study Start Date: December 2010
Study Completion Date: March 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Magnesium group
Intravenous Magnesium Sulfate
Drug: Intravenous Magnesium Sulfate
40 mg/kg (max 2.4 grams), infused at a concentration of 40 mg/ml (1 ml/kg, max 60 ml), every 8 hours for a total of 6 doses
Placebo Comparator: Placebo group
Normal Saline placebo
Drug: Normal Saline Placebo
(1 ml/kg, max 60 ml), administered every 8 hours for a total of 6 doses

Detailed Description:

It is well known that children with sickle cell disease are at risk for acute pain crises. The usual treatment for these pain crises, intravenous fluids and pain medicines such as morphine, has changed little over the past three decades. In a pilot study, the addition of intravenous magnesium to standard therapy decreased length of stay; however, this study was not randomized, not blinded, not placebo-controlled, and not adequately powered to assess safety.

We will conduct a multi-center, randomized, double-blind, placebo controlled trial of about 208 children, ages 4-21 years. Patients will be randomized to receive intravenous magnesium sulfate or placebo every 8 hours for a total of 6 doses, or until discharge. Patients will return for a routine clinic visit up to 3 months after discharge for a baseline assessment. Patients will also complete health-related quality of life measures at 4 timepoints throughout the study.

  Eligibility

Ages Eligible for Study:   4 Years to 21 Years   (Child, Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age 4-21 years, inclusive
  • Sickle cell anemia (Hb SS) or Sickle beta zero thalassemia disease (Hb Sβ°)
  • failed intravenous opioid pain management in the emergency department prior to the decision to admit the patient
  • admitted to the inpatient unit for sickle cell pain crisis

Exclusion Criteria:

  • patient received more than 12 hours of intravenous pain medication prior to enrollment
  • previous enrollment in this study (only one admission per child is eligible)
  • history of allergy/intolerance to both intravenous morphine and hydromorphone
  • known other cause for pain (avascular necrosis, gall bladder disease, priapism, etc.)
  • patient with greater than 10 admissions for pain crisis in the past year
  • patient maintained on daily opioids or chronic transfusions for chronic sickle cell pain
  • transfusion within the previous two months
  • known kidney or liver failure (elevation of liver function tests does not warrant exclusion)
  • known pulmonary hypertension
  • pregnancy
  • diagnosis of bacterial infection, fever ≥39.5°C, acute chest syndrome, hemodynamic instability or sepsis
  • current oral magnesium supplementation or current enrollment in another therapeutic study protocol
  • previously diagnosed clinical stroke
  • current or planned use of neuromuscular blocker, nifedipine, ritodrine, or terbutaline
  • allergy to magnesium sulfate
  • discharge from an inpatient unit within 72 hours of arrival in the emergency department for the current pain crisis
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01197417

Locations
United States, Illinois
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States, 60611
United States, Maryland
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
United States, Michigan
Children's Hospital of Michigan
Detroit, Michigan, United States, 48201
United States, Ohio
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
United States, Pennsylvania
Children's Hospital of Philadelphia Research Institute
Philadelphia, Pennsylvania, United States, 19104
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
United States, Texas
Baylor College of Medicine
Houston, Texas, United States, 77030
United States, Wisconsin
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
Medical College of Wisconsin
Pediatric Emergency Care Applied Research Network
Investigators
Principal Investigator: David Brousseau, MD, MS Medical College of Wisconsin
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Medical College of Wisconsin
ClinicalTrials.gov Identifier: NCT01197417     History of Changes
Other Study ID Numbers: PECARN 025 
Study First Received: August 31, 2010
Results First Received: August 5, 2015
Last Updated: December 21, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Medical College of Wisconsin:
Sickle Cell Disease
Magnesium Sulfate
Pediatric

Additional relevant MeSH terms:
Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn
Magnesium Sulfate
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics
Central Nervous System Depressants
Anti-Arrhythmia Agents
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Tocolytic Agents
Reproductive Control Agents

ClinicalTrials.gov processed this record on September 26, 2016